Status:
TERMINATED
Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Conditions:
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy, as measured by overall response (complete response (CR) + partial response (PR)) of ofatumumab in combination with bortezomib in subjects with relaps...
Eligibility Criteria
Inclusion
- Patients must have biopsy sample obtained within 6 months of study entry that:
- Is histologically confirmed DLBCL, MCL or FL, by an Oregon Health and Science University (OHSU) hematopathologist
- Retains expression of CD20+
- Patients must be refractory to or have recurrent disease after prior rituximab containing treatment; relapse or progression is defined according the International Working Group (IWG) response criteria
- FL patients must have disease-related symptoms, cytopenias, threatened end-organ function, bulky or progressive disease, or it is the patient's preference to be treated
- DLBCL and MCL patients must be either transplant ineligible or have refused high dose therapy
- Patients must have radiographically measurable disease, as defined by the IWG criteria; the same method of assessment used to measure each lesion at baseline must be used for all subsequent tumor measurements throughout the study
- There is no limit to the number of prior treatments
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Absolute neutrophil count \>= 1.0 K/mm\^3
- Platelets \>= 50 K /mm\^3
- Total bilirubin =\< 1.5 x normal institutional limits, unless secondary to Gilbert's disease
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =\< 2.5 x institutional upper limit of normal (ULN)
- Alkaline Phosphatase \< 2.5 times ULN (unless due to disease involvement of the liver or bone marrow)
- Patients must be able to comply with study procedures and follow-up examinations
- Women of childbearing potential (not surgically sterile or \< 12 months naturally post-menopausal) must be willing to use medically accepted method of contraception for the duration and 6 months following the end of the treatment; acceptable methods of contraception include abstinence, barrier method with spermicidal or hormonal contraceptive (oral, transdermal, implanted and injected) in conjunction with a barrier method
- Men who are not surgically sterile must practice abstinence or use a barrier method of birth control for the duration and 6 months following the end of treatment
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion
- Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Patients who have had chemotherapy, antibody or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C); corticosteroids for symptom control are allowed up to 7 days of starting protocol treatment
- Patients may not have received any other investigational agents within 4 weeks, or may not be currently participating in any other interventional clinical study
- Prior treatment with ofatumumab or bortezomib
- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
- Diagnosis of another malignancy, unless the patient has been disease-free or at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or bortezomib
- Peripheral neuropathy or neuropathic pain of Grade 2 or greater
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or anti-viral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis
- History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association (NYHA) III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
- Pregnant or breast feeding women
- Known human immunodeficiency virus (HIV) infection
- Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAG but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed; if positive the subject will be excluded
- Active hepatitis C infection (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case the investigator should reflexively perform a HC Recombinant Immunoblot assay (RIBA) on the same sample to confirm the result
- Known lymphoma involvement of the central nervous system (CNS)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01397591
Start Date
October 1 2011
End Date
July 1 2013
Last Update
July 30 2014
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239